Kornimate/medical-research-clean huggingface dataset:
a double-blind "preferred" vardenafil dose study of qol and functional outcomes in males with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: to find out more information on how treating impotence with vardenafil in comparison to placebo affects the quality of life (qol) of men and their partners. subjects will receive 10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of vardenafil may be reduced to 5mg or increased to 20mg. subjects will then receive their 'preferred' dose for 14 weeks. during this time quality of life measures will be collected via questionnaires


Eligibility criteria:
inclusion criteria: * males with erectile dysfunction for more than six months according to the nih consensus statement (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) * stable, heterosexual relationship for more than six months * documented written informed consent, from both the patient and his partner, after receiving adequate previous information and prior to any study specific procedures. * an ed-eqol score \< or = 15.- an iief score \< or = 25. exclusion criteria: * presence of penile anatomical abnormalities (eg. penile fibrosis or peyronie's disease) that would significantly impair erectile function. * history of radical prostatectomy. - retinitis pigmentosa. * history of positive test for hepatitis b surface antigen (hbsag) or hepatitis c.- unstable angina pectoris. * history of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia within the prior 6 months. * atrial tachyarrhythmia (eg. atrial fibrillation/flutter) with a heart rate of \>100 beats per minute at screening. * child-pugh class b liver disease or liver function abnormalities. * clinically significant chronic haematological disease or bleeding disorder * history of significant peptic ulcer disease within one year before visit 1 * resting hypotension (a resting systolic blood pressure of \ 170 mm hg or a resting diastolic blood pressure \>110 mm hg). * symptomatic postural hypotension within the six months of visit 1. * uncontrolled diabetes mellitus (haemoglobin a1c \> 12%). * patients who are taking nitrates or nitric oxide donors (e.g. molsidomine). * patients who are taking anticoagulants, with the exception of anti-platelet agents. * patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens. * patients who are taking the following inhibitors of cytochrome p 450 cyp 3a4: potent hiv protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.

Keywords: erectile dysfunction quality of life
docetaxel plus oxaliplatin as therapy in patients with pancreatic cancer

Conditions: Pancreas Neoplasms

Summary: the purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.

for years fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. since 1997 gemcitabine is also a standard therapy with in comparison to fluorouracil a significant better clinical benefit. but after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer. so the purpose of this study is to test the combination of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.

Eligibility criteria:
inclusion criteria: * dated and signed informed concent * histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium uicc iii/iv) * presence of at least one measurable (according to recist criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy * failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: progress within 3 months after a first-line therapy discontinuation of a first-line therapy due to toxicity * age \>= 18 years * karnofsky index \> 60% * expected live span \> 12 weeks * sufficient bone marrow reserve: granulocytes \>= 1.5 x 109/l and platelets \>= 100 x 109/l and hemoglobin \>= 9 g/l * serum bilirubin \< 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed) * ast/alt \< 2.5 x upper normal limit exclusion criteria: * every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible * pregnancy or lactation * patients able to reproduce that do not adhere to strict contraception * presence of brain metastasis * severe, uncontrolled infection * preexisting peripheral neuropathy \> grade i * preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia * justified disbelief in the compliance of the patient * parallel participation in another clinical trial

Keywords: adenocarcinoma of the pancreas pancreatic cancer pancreas carcinoma advanced pancreatic cancer metastatic pancreatic cancer second line palliative oxaliplatin docetaxel taxotere eloxatin cancer of pancreas pancreas cancer
the influence of the crown-implant ratio on the crestal bone level and implant secondary stability

Conditions: Partial Edentulism; Tooth Loss

Summary: the aim of the study was to determine whether implant length and the crown-to-implant (c/i) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.

the patients participating in the study (n=30) had one single tooth implant - a short (osseospeed™ l6ø4 mm, implants) or a regular implant (osseospeed™ l11 and l13ø4 mm, dentsply implants) - placed in the maxilla. the evaluation was based on clinical and radiological examination. the crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. mean crown-to-implant ratios were calculated separately for each group and its correlation with the mbl (marginal bone loss) and stability was assessed. the authors compared the correlation between the c/i ratio values, mbl and secondary implant stability.

Eligibility criteria:
inclusion criteria: * non-smoking patients with no systemic or local diseases were qualified. additional inclusion criteria were as follows: * minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification * minimal width of the alveolar ridge of 6-7 mm in the region of interest * hkt (height of the keratinized tissue) higher than 2 mm * api ≤ 35 (approximal plaque index) * pi ≤ 25. (plaque index) * bone type iii or d2 were included in the study * no graft procedures in the area of interest, exclusion criteria: -

Keywords: implant dental implant
bortezomib (velcade) + pemetrexed (alimta) in advanced nsclc

Conditions: Non-small Cell Lung Cancer

Summary: pemetrexed is an fda-approved treatment for advanced lung cancer but the response rate is still very low. bortezomib is currently approved to treat myeloma in patients who have already been treated. currently, multiple studies are actively investigating how well bortezomib works with other drugs. this study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. this study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.


Eligibility criteria:
inclusion criteria: * unresectable locally advanced (stage iiib) or metastatic (stage iv) nsclc who have received one prior platinum-based chemotherapy regimen. * one prior treatment with any biologically targeted agent is acceptable * stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days. * ecog performance status of 0 or 1. * measurable and/or evaluable indicator lesion(s). * adequate hematologic, renal and hepatic function * patient is of a legally consenting age * patient has a life-expectancy \>2 months. * voluntary written informed consent before performance of any study-related procedure * female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study. * male patient agrees to use an acceptable method for contraception for the duration of the study. exclusion criteria: * prior treatment with pemetrexed (alimta) or bortezomib (velcade). * patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ. * peripheral neuropathy nci grade \> 2. * symptomatic or uncontrolled brain metastasis. * radiation therapy to major bone marrow (\> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry. * patient has received other investigational drugs with 14 days before enrollment. * serious medical or psychiatric illness likely to interfere with participation in this clinical study. * any systemic therapy within 21 days prior to study entry. * patient known to be human immunodeficiency virus (hiv)-positive. * patient had a significant cardiac event within 6 months of enrollment * history of arrhythmia * congenital long qt syndrome or 1st degree relative with unexplained sudden death under 40 years of age. * qt prolongation with other medications that required discontinuation of that medication. * presence of left bundle branch block (lbbb). * qtc ≥480 msec or greater on screening ecg. * patient has hypersensitivity to bortezomib, boron or mannitol. * female patient is pregnant or breast-feeding.

Keywords: nsclc
pompe disease registry protocol

Conditions: Glycogen Storage Disease Type II; Pompe Disease

Summary: the pompe registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. data from the registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. the objectives of the registry are: * to enhance understanding of the variability, progression, identification, and natural history of pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * to assist the pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * to characterize the pompe disease population. * to evaluate the long-term effectiveness of alglucosidase alfa.

study design time perspective: retrospective and prospective

Eligibility criteria:
inclusion criteria: all patients with a confirmed diagnosis of pompe disease who have signed the informed consent and authorization form(s) are eligible for inclusion. confirmed diagnosis is defined as documented gaa enzyme deficiency from blood, skin, or muscle tissue and/or documentation of 2 gaa gene mutations. exclusion criteria: there are no exclusion criteria in this registry

Keywords: glycogen storage disease type ii (gsd-ii) gsd-ii pompe disease pompe disease (late-onset) acid maltase deficiency disease glycogenosis ii
diabetes resistance training adaptations in elderly

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims to verify the effects of resistance training on neuromuscular, vascular and functional adaptations of elderly diabetics type 2. half of participants will be the intervention group that will perform resistance training, while the other half will be the control group that will perform stretching sessions.

resistance training may be an interesting strategy to fight diabetes deleterious conditions, as it is known to increase muscle mass and quality, strength, functional capacity, vascular health, and decrease inflammation status and blood lipids, besides leading to improves in glycemic control. to test this hypothesis, 42 diabetic patients will be recruited and randomized to two groups that will be evaluated before and after 12 weeks of both intervention or control period. the resistance training group will perform all body resistance exercises three times per week, while the control group will perform a stretching session one time per week.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * 60 yers and older * hba1c \> 6,5% * bmi from 18,5 kg/m2 - 34,9 kg/m2 exclusion criteria: * current smoking * insulin users * hypertension uncontrolled * diabetic neuropathy * diabetic retinopathy * diabetic nephropathy * peripheral amputations * clinical depression * myocardial infarction (within past 6 months) * any unstable chronic condition * muscle-skeletal complications that limit the practice of the exercises
description and evaluation of eating disorders in elite athletes (tca shn)

Conditions: Eating Disorders; Anorexia Nervosa; Boulimia Nervosa; Binge Eating Disorders

Summary: athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. these eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described. our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.


Eligibility criteria:
inclusion criteria: * to have at least 12 years * to be registered on the high level sportsmen list or to be in access to high level sport * to have obtained the non opposition of the athlete if he is major (if not the legal person in charge of the athlete have to give is non opposition). * to be affiliated to social security exclusion criteria: * presenting obvious cognitive disturbance * not able to understand or/ and to read french language * pregnant women * subject under tutelage

Keywords: reverse anorexia, anorexia athletics
early assessment of qfr in stemi-ii

Conditions: ST Segment Elevation Myocardial Infarction

Summary: the study intends to provide new data on whether the noval method using quantitative flow ratio could assess microvascular dysfunction based on the previous study early-myo-qfr-i.

microvascular dysfunction (mvd) is a serious complication of pci, which happens frequently after stemi and always correlates with a poor prognosis. however, precise and simplified assessment of mvd is difficult, especially in the acute phase of stemi patients. resent studies suggested that ffr could be overestimated when mvd exists. but whether the overestimated value of ffr caused by cmr defined microvascular obstruction (mvo) could reflect microvascular function is still unclear. in the previous study early-myo-qfr-i, we have demonstrated that the relationship between contrast-enhanced cmr defined mvo and qfr. while angiography images were collected on a retrospectively manner, and the study population were selected (stemi patients with spontaneously recanalized culprit vessel before pci) to verify our hypothesis. this phase of study would be a prospective study. we tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in stemi patients.

Eligibility criteria:
inclusion criteria: * stemi patients treated with revasculation within 12 hours from onset of symptoms to pci time and received cmr 5 days afterwards. stemi was defined as a combination of the following: chest pain for more than 30min, electrocardiographic (ecg) changing with st segment elevation of \>2 mm in at least 2 precordial leads and \>1 mm in limb leads, and abnormal troponin levels or ckmb levels higher than twice the upper limit of normal. * stents were implanted whenever technically possible. * tfg 2/3 after pci. exclusion criteria: * patients with left bundle branch block in the presenting ecg, cardiogenic shock, previous pci or bypass surgery, previous ami history. * patients with trouble in partially inflating a balloon catheter during pharmacologic hyperemia. * patients with unqualified coronary angiographic images with problems such as ostial lesion, severe vessel tortuosity and diffuse long lesions.

Keywords: stemi cardiac magnetic resonance balloon catheter
effects of acute intake of caffeinated beverages in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive performance in patients with type 1 diabetes. knowledge acquired may inform a wider study of the impact of these drinks. this is a randomised, cross over blinded study in which all participants will participate in the 3 arms of the study. the study will consist of 3 phases, each lasting 3 days. a different study drink will be administered during each phase. there will be an initial screening visit and a pre- study visit before each study phase. each participant will make 10 visits to the research centre. there will be a week wash out period between each study phase. prior to each study phase, there will be a 3 day caffeine and alcohol abstinence run-in period. study drinks will be matched for taste and volume (as far as possible) and will be administered by the use of opaque cups, lids and straws to enable double-blind randomisation for both researcher and participants. administration of the study drink to participants will be based on latin squares to provide a balanced treatment order. during the 3 days study period; participants will be required to abstain from all other caffeine containing beverages or confectioneries. the secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced energy drinks is developed following acute short term ingestion.


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥18 years * confirmed diagnosis of type 1 diabetes of more than one year duration * participants who use multiple daily injections of basal and meal-time analogue insulin. * ability to perform daily finger stick measurements of blood glucose levels * adequate contraceptive control * provision of informed consent exclusion criteria: * hypoglycaemia unawareness * coronary heart disease * cardiac arrhythmia * structural heart lesions, * autonomic neuropathy * psychiatry illness, * epilepsy * migraine * caffeine intolerance * unable to provide informed consent

Keywords: type 1 diabetes caffeine-enhanced energy drink cardiac output glucose cognitive performance
aspiration of excessive endometrial fluid at the day of ovum retrieval plus diosmin in (icsi) cycles

Conditions: Infertility

Summary: to notify the effect of aspiration of excessive endometrial fluid in addition to diosmin in cases undergoing intracytoplasmic sperm injection (icsi) cycles.

objectives: to notify the effect of aspiration of excessive endometrial fluid in addition to diosmin in cases undergoing intracytoplasmic sperm injection (icsi) cycles. study design: prospective randomized controlled clinical trial. patients and methods: 200 women with excessive endometrial fluid by transvaginal ultrasound during icsi cycles are randomly scheduled into two equal groups. in group a, one tab every 8 hs diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an iui catheter ; while in group b (control group), no thing is given or done. the main outcome measures are presence of the fluid on the day of embryo transfer and the pregnancy rate on those patients.

Eligibility criteria:
inclusion criteria: * women with excessive endometrial fluid by transvaginal ultrasound during icsi cycles exclusion criteria: * none
virtual reality and pain perception during exercises for patients with chronic non-specific low back pain

Conditions: Chronic Low Back Pain

Summary: immersion in a virtual reality environment has been shown to reduce pain during a variety of painful medical procedures, such as wound care for burn patients and dental care. often, serious games are used to distract patients from this painful procedures. recently, serious games have also been developed for patients with low back pain. because patients with low back pain frequently experience pain during exercises, the investigators hypothesize that exercising with serious games can reduce the pain intensity and the time spent thinking of pain during exercises. to test this hypothesis, the investigators will conduct a randomized controlled trial where two groups will be compared: the experimental group will perform one session of exercises with serious games, while the control group will perform one session of the same exercises without the serious games.


Eligibility criteria:
inclusion criteria: * chronic non-specific low back pain, with or without referred pain to the legs * age 18-65 * able to understand dutch * a minimum pain intensity of 3/10 on the numeric pain rating scale at the time of the test * being familiar with pelvic tilt exercises exclusion criteria: * spinal surgery in the past * pregnancy * serious underlying pathologies (e.g. multiple sclerosis, tumors,...) * signs or symptoms of nerve root involvement * known skin-allergy for tape

Keywords: chronic low back pain virtual reality serious gaming exercise therapy distraction
shared decision-making and dialysis choice

Conditions: Chronic Kidney Diseases

Summary: the sdm-dc intervention is designed for patients with kidney failure who must make a decision regarding type of dialysis: haemodialysis or peritoneal dialysis. sdm-dc consists of patient and his or her relative(s) being given a patient decision aid called 'dialysis choice' and booked for meetings with a dialysis coordinator.

the dialysis coordinators were trained in the why, what and how in relation to sdm-dc and to deliver the intervention by tailoring to patients' needs and using three different communication skills: mirroring, active listening and value clarification. the patient decision aid was designed to be utilised during and between the sdm-dc meetings. the patient decision aid is in paper format and consists of a set of tools: a decision map, an overview of uremic symptoms, an overview of options, and the ottawa personal decision guide. more specifically, the patient decision aid makes explicit the dialysis decision, describes options, benefits and harms using the best available evidence, and intends to help patients clarify their values by indicating the importance of the benefits and harms out of scale from (0) to (5). four videos with personal stories were available to be shown and discussed at the meetings if the patient preferred to see the reason why another patient has chosen a specific option. each video showed one option with a patient telling why he/she chose that option, and how he/she weighed the advantages and disadvantages.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate below 20 ml/min * a clinical judgement made by the contact nurse and the contact physician exclusion criteria: * conservative care * a set date for a transplantation with a living donor * not able to participate due to cognitive impairment